The invention is related generally to a system and method for wirelessly tracking medical items through the use of RFID tags, and more particularly, for tagging and encoding medical items with RFID tags in a bulk manner.
Most medical items are produced with human-readable labeling that identifies the characteristics of the medical item so that it may be administered safely to a patient. For example, an administering nurse reads the label on the container of a tablet meant to be swallowed and determines from the label that the tablet in the container is 350 mg of a certain drug. The container may also have an expiration date for the tablet, a lot number, and other information. In other cases, the container may include the National Drug Code (“NDC”) for the tablet and any applicable warnings. The U.S. Food and Drug Administration (“FDA”) presently requires human-readable labeling. Such labels are typically attached to containers of medication with adhesive before the container leaves the manufacturer. Because of the adhesive, they can be difficult to remove. Due to FDA regulations and the adhesive used, they are considered to be integral with the medical item and the container.
Title 21 of the Code of Federal Regulations presents a comprehensive scheme for human-readable drug labeling. Medical items falling under the jurisdiction of the Food and Drug Administration must be labeled in a certain way to satisfy the laws and regulations. Following the regulations results in medical items that can be clearly identified simply by reading their integral labels. However, attempting to track medical items in a healthcare facility by means of visually reading the label of each medical item is impractical.
Automation has been developed in this area. For example, RFID systems have been developed to assist in tracking medical items from their receipt at a healthcare facility through the administration of the medical item to a patient. RFID systems have resulted in a great benefit to healthcare facilities in that medical items can be tracked wirelessly. However, an RFID transponder (also referred to as an RFID “tag”) must be attached to the medical item to enable this system to function and must also be associated with data about the medical item to which the RFID tag is attached.
Read-only RFID tags are often used and each has a unique serial number (according to their manufacturers) that is used to identify the tag. When the read-only RFID tag is activated, it transmits its unique serial number. In the case of read-only RFID tags, a database of some type is needed to then correlate the serial number of an RFID tag with the medical item to which it is attached. Read-only RFID tags are manufactured in enormous quantities and are relatively inexpensive.
Writable RFID tags also exist. These tags not only include a unique serial number but also include a memory of a certain size to which data can be written. When these writable RFID tags are activated in the “write” mode, data about the medical item to which they are attached can be written to their memories. When activated and controlled to be in the “read” mode, the RFID tags transmit their unique serial number and the data stored in their memories. In some cases, a unique serial number for a writable RFID tag may not be needed. Writable RFID tags are more expensive than read-only RFID tags.
The FDA has been aware of RFID systems and in 2004 it published the FDA Compliance Policy Guide (“CPG”) § 400.210 which addressed the use of RFID tags attached to drugs. This document provided general guidance by the FDA in 2004 that RFID will be used only for inventory control, tracking, and tracing of products. RFID will not be used in lieu of current labeling control systems. The tags will contain a serial number that uniquely identifies the object to which the tag is attached. The addition of the RFID tag will not block, obscure, or alter any of the product's existing and approved label and labeling information. The RFID tag will not substitute for, replace, or interfere with a linear bar code required pursuant to 21 CFR § 201.25. This latter requirement would provide the ability to identify the drug when electronic means are unavailable.
Many healthcare facilities purchase large quantities of medical items to be administered to their patients. Those medical items are received at the healthcare facility from manufacturers, distributors, or repackagers and have the human-readable labeling on them as required by the FDA. Because there is no FDA requirement for the attachment of an RFID tag by a manufacturer, distributor, or repackager, many of these received medications are delivered to the healthcare facility without one. If the facility desires to track these delivered medical items through the use of an RFID system, it must attach the RFID tags itself while bearing in mind the above-listed FDA policy guidance that the human-readable labeling should not be blocked, obscured, or altered by attachment of the RFID tag.
In many healthcare facilities, automation of medical item tracking has been put in place because of the many benefits it provides. Where that system comprises the use of RFID tags on medical items, the contents of a medical item and its characteristics, including those characteristics relevant to safety of use, are typically stored in a computer database. The RFID tags placed on the medical items are in many cases read-only devices that transmit only their individual serial number when they are read. The RFID tracking system associates that RFID tag serial numbers with the information in the database pertaining to the medical item to which the RFID tag is attached and thereafter, when the tracking system reads the serial number of the RFID tag attached to the medical item, the computer will identify the medical item information thereof. The tracking system generally prescribes that medical items are to be immediately tagged with RFID tags and associated with database data as soon as possible after arrival at the healthcare facility. A problem can arise when the serial number of the RFID tag is associated with the wrong data in the database when this initial tagging operation is performed.
FIGS. 1 and 2 show one technique for attaching an RFID tag 10 to a drug vial 12 that is in use presently. FIG. 1 shows the front of the vial and FIG. 2 shows the back. The vial 12 includes an integral human-readable label 14 containing FDA-required printed information about the contents of the vial. A second label 16 is attached to the vial 12 with clear adhesive tape 18. On the front side 20 of the second label 16 shown in FIG. 1, human-readable information copying that on the integral label 14 is present on a printable area 21 of the tag. On the back side 22 of the second label 16 shown in FIG. 2, only the mounted RFID tag 10 exists. It can be noted that the front side 20 of the second label 16 has identical information (drug name, NDC, manufacturer name, and expiration date) as some of the information of the integral FDA-mandated label 14. Unfortunately, if the human-readable information on the second label 16 does not match that on the integral first label 14, the inconsistency can lead to a medical error.
Furthermore, the second label 16 of FIGS. 1 and 2 was printed with the information from the integral label 14 on the printable area 21 of the first side 20 before the label 16, which includes the RFID tag 10, was attached to the vial 12. If the RFID tag 10 had been read after printing but before it was attached to a vial, and its serial number then associated with a vial in a computer database at the healthcare facility, a problem could develop if that second label 16, along with its RFID tag 10, is then attached to the wrong vial. In such a case, a medical error could occur.
It is believed that in the above procedure, a plurality of second labels are printed before attaching any of them to a vial. This may be considered to be a bulk encoding technique in such a case. To be successful, this procedure requires that the correct second labels be attached to the correct vials. Human effort is required in comparing the second labels to the integral labels before attaching the second labels. Such a procedure can be prone to error, as mentioned above.
Similar encoding of the serial numbers of RFID tags to data stored in a database can be beneficial in other areas in which medical items are tracked. Manufacturers, repackagers, and distributors of medical items all may need to attach RFID tags to medical items and encode those RFID tags to a database or databases. In such cases, bulk encoding could greatly improve the speed of encoding the RFID tags and its accuracy.
Hence those of skill in the art have recognized a need for an RFID tag tracking system that results in more accurate tagging and data association. In the medical field, a need has been recognized for accurately encoding RFID tags to the correct medical item and for avoiding errors in attaching RFID tags to medical items. A need exists for avoiding second labels that have human-readable information printed thereon that could be inconsistent with an integral label on same medical item due to human error. Another need has been recognized for avoiding the association of the wrong serial number of an RFID tag with data in the database. Yet a further need exists for encoding multiple items simultaneously to increase the speed of encoding, yet reducing the chances for errors in encoding. The present invention fulfills these needs and others.